Paragraph IV Disputes Master Symposium

Opening Remarks from the Co-Chairs

Laura DeMoor
Associate General Counsel, IP
Baxter Healthcare Corporation

Andrea D. Tiglio, PhD, JD
Executive Director
Assistant General Counsel, Intellectual Property
Jazz Pharmaceuticals

Patents, Drug Pricing, and Price Controls: Understanding How the Inflation Reduction Act (IRA) Will Impact The Value of Pharmaceutical IP

John T. Bennett
Partner
Allen & Overy LLP

Anita Spieth
Co-Chair, IP Litigation
Choate, Hall & Stewart LLP

• Analyzing how the IRA’s provisions on drug pricing is impacting pharmaceutical patents
• Understanding how price negotiation may circumvent pharmaceutical patent values
• How is the value of IP impacted when drugs are not approved for Medicare/Medicaid formularies?
• How does renegotiation affect the value of the drug’s patent?
• Appreciating the significance of Merck v. Becerra with respect to pro-competitive intent of Hatch-Waxman?
• Evaluating the potential impact of the IRA on pharmaceutical patent litigation
• What happens when a patent holder’s product is selected for negotiation before or during litigation?
• What is the impact on recoverable damages in an at-risk launch scenario?
• Understanding the impact on coordination and discovery
• Exploring how the IRA can encourage settlement of infringement litigation
• Practical strategies for safeguarding IP value when your drug is selected for negotiation

Chief IP Counsel Roundtable

Day-to-Day Concerns and Forward-Looking Strategic Planning

Neema Kumar
Vice President, IP, North America
Sandoz

James P. Leeds
Vice President and Chief Patent Counsel – Hatch Waxman Litigation
Eli Lilly & Company

Lars P. Taavola
VP, Chief IP Counsel & General
Counsel, Specialty Generics
Mallinckrodt Pharmaceuticals

Moderator:

William A. Rakoczy
Founding Partner
Rakoczy Molino Mazzochi Siwik LLP

Pharmaceutical Chief IP Counsel sit at the helm of the Hatch-Waxman litigation nerve center where they navigate the ever-evolving landscape of pharmaceutical patent litigation. With the intent of IP protection preservation or defeat at the forefront of their agendas, these panelists will discuss best practices and strategies they employ to control or covet patents and profits.

Brand Perspectives

• Appreciating the importance of patents for innovation
• Understanding the keys to growing a strong portfolio
• Orange Book listing strategies
• Gauging when to expect a Paragraph IV lawsuit

Generic Perspectives

• Determining which patents are ripe to challenge in today’s environment
• What makes one patent more attractive than another?
• Evaluating invalidity and non-infringement for the patent target
• Formulating your ANDA strategy

Considerations for Both Sides

• Deciding when to refer to outside counsel and detailing which matters typically remain in-house
• Taking stock of significantly challenging situations and predicting the challenges in-house lawyers will face in the future

Networking Coffee Break

Insights on the Future of §112: Satisfying the Requirements of Enablement and Written Description under Amgen v. Sanofi

Mary C. Till
Senior Legal Advisor
Office of Patent Legal Administration
U.S. Patent and Trademark Office

Jason Murata
Partner
Axinn, Veltrop & Harkrider LLP

Emily Larrimer Savas
Partner
Locke Lord LLP

Emer Simic
Partner
Neal, Gerber & Eisenberg LLP

• Analyzing the Supreme Court’s decision in Amgen v. Sanofi relative to the enablement requirement
• Taking stock of what the decision means when a patent claims a class of novel compounds or antibodies
• Understanding the impact of the decision on the ability to protect broader foundational innovations
• Reviewing the impact of other influential §112 cases, such as Juno, Biogen and Idenix
• Reconciling whether patentees must disclose enough information to “enable” people of ordinary skill in the relevant art to “reach the full scope” of a claimed invention
• Assessing how the decision could make changes to the Federal Circuit’s approach
• Implementing best practices for patent prosecution in view of the Court’s decision

The Pain of Rejection: A Deep Dive into the Business and Legal Implications of the Supreme Court’s Denial of Cert. in Recent Patent Eligibility and Carve-Out Cases

Jay R. Deshmukh
Partner
Kasowitz Benson Torres LLP

Steven J. Horowitz
Partner
Sidley Austin LLP

Alejandro Menchaca
Shareholder
McAndrews, Hel & Malloy, Ltd

James T. Peterka
Partner
Locke Lord LLP

Irena Royzman
Partner
Kramer Levin Naftalis & Frankel LLP

Last Spring, despite the push from the U.S. Solicitor General, the Supreme Court declined to hear three key patent cases, two cases involving §101, Tropp v. Travel Sentry et al. and Interactive Wearables v. Polar Electro Oy, et al., and the infamous GSK v. Teva.

During this session, our panelists will analyze the significance of the Supreme Court’s refusal to hear these cases and explore the potential impact on Hatch-Waxman litigation strategies. They will also market dynamics, and the overall impact of these rejections on the pharmaceutical IP landscape. Points of discussion will include:

• Uncovering the business consequences stemming from the Court’s refusal to hear these cases
• Exploring how these decisions may collectively affect the balance of power between brand-name drug manufacturers and generic challengers, market entry opportunities, and the overall competitive landscape
• Assessing how lower courts may interpret and apply the existing § 101 and carve-out legal frameworks
• Evaluating the potential impact of the absence of the Supreme Court’s pronouncement on the evolving landscape of pharmaceutical patent disputes in the areas of patent eligibility and skinny labeling

Networking Luncheon

Sponsored by:

What Every U.S. Pharmaceutical Patent Litigator Needs to Know About the Unitary Patent (UP) and the Unified Patent Court (UPC)

Liz Cohen
Partner
Bristows LLP

Sarah Fendrick, Ph.D., J.D.
Director, Patent Counsel
Alnylam Pharmaceuticals

Ha Kung Wong
Partner
Venable LLP

Ruud van der Velden
Partner
Hogan Lovells

The introduction of the UP and the establishment of the UPC have far-reaching implications for pharmaceutical patents issued in the U.S. that cannot be ignored. Without an understanding of the UP and the UPC, pharmaceutical patent holders in the U.S. may not be able to globally protect innovations. This undoubtedly would hinder cost savings, as well as compromised streamlined portfolio management and limit alternative enforcement options.

During this session, our global thought-leaders will delve into the intricacies of the UP and the UPC, and explore their significant impact on the global patent ecosystem. Topics of discussion will include:

• Understanding why U.S. pharmaceutical patent practitioners need to know about the UP and the UPC
• Exploring the UP and the UPC, including their legal frameworks and operational procedures
• Evaluating the associated advantages and disadvantages of the UP and the UPC and how they may impact your global patent portfolio
• Navigating the UPC’s jurisdiction and the potential risks and opportunities associated with litigating in this new court system.
• Developing offensive litigation strategies for the UPC, as well as defensive strategies if you believe you will be sued in the UPC
• Understanding the interplay between opposition proceedings at the EPO and validity challenges in the UPC

Patent Reissue and Reexamination in the Hatch-Waxman Realm: Strategies for When to Pursue and Correct Patent Errors

Vikram A. Mathrani
Partner
Hongiman LLP

Joseph Reisman
Partner
Knobbe Martens

Gregory A. Morris
Partner
O’Melveny & Myers LLP

In this session, our panelists will navigate the legal nuances and practical implications of patent reissue and reexamination in Hatch-Waxman litigation. Topics of discussion will include:

• Assessing how these processes can influence the strength, scope, and enforceability of pharmaceutical patents
• Understanding the impact on market exclusivity, generic drug entry, and patient access to affordable medications
• Analyzing the key considerations when deciding to pursue reissue/reexaminaiton in a Hatch-Waxman scenario
• Grounds for filing
• Process before USPTO
• Timing
• Identifying the risks and limitations of utilizing reissue proceedings to resolve patent errors
• Employing a cost-benefit analysis while your patent application is pending
• Reconciling when supplemental examination is beneficial relative to reissue

Afternoon Refreshment Break

MAGISTRATE TOWN HALL

Understanding the Roles of the Magistrate Judges and Local Counsel in Paragraph IV Proceedings

Hon. Tonianne J. Bongiovanni
Magistrate Judge
United States District Court, District of New Jersey

Hon. Christopher J. Burke
Magistrate Judge
United States District Court, District of Delaware

Moderator:

Adam W. Poff
Partner
Young Conaway Stargatt & Taylor, LLP

In the complex landscape of pharmaceutical patent disputes, these esteemed magistrate judges play a pivotal role in ensuring fair and efficient resolution of cases. With their unique perspective, Magistrate Judges bring a wealth of knowledge to the bench, navigating the intricate interplay between pharmaceutical innovation and intellectual property rights.

During this session, Magistrate Judges from the most active jurisdictions will share their invaluable insights and experiences, shedding light on the critical decisions they make and the profound impact they have on shaping the future of pharmaceutical patent litigation.

VIEW FROM THE FEDERAL BENCH

District Court Judges on the Present State of Paragraph IV Litigation: Filing Trends, Settlements and Timings

Hon. Joshua Wolson
District Judge
United States District Court, Eastern District of Pennsylvania
(Visiting Judge, District of Delaware)

Interviewed By:

Arlene Chow
Partner
Latham & Watkins LLP

District Court Judges are at the forefront of shaping the landscape of pharmaceutical IP law.

During this can’t-miss roundtable, distinguished District Court Judges will share their unique perspectives, illuminating the delicate balance between patent holders, generic drug manufacturers, and public interest.

Conference Adjourns to Day Two

Opening Remarks

Laura DeMoor
Associate General Counsel, IP
Baxter Healthcare Corporation

Andrea D. Tiglio, PhD, JD
Executive Director
Assistant General Counsel, Intellectual Property
Jazz Pharmaceuticals

Brand and Generic Insights on FDA Programs Impacting Pharmaceutical Patents: Regulatory Initiatives and Recent FDA Litigation Every PIV Practitioner Needs to Know About

Maryll W. Toufanian
Senior Vice President, Regulatory Strategy and Policy
Amneal Pharmaceuticals

Maarika L Kimbrell
Partner
Morgan, Lewis & Bockius LLP

For Hatch-Waxman litigators, staying up to date with new FDA regulations is crucial. By monitoring these developments, Hatch-Waxman litigators can adapt their strategies, assess the potential impact on patent validity and infringement disputes, and navigate the evolving landscape of pharmaceutical patent litigation effectively. During this session, our panelists will help you understand the nuances of new regulations and initiatives, empowering you to provide valuable insights, and advocate for your clients’ interests.

Topics of discussion will include:

• Exploring the progress of the FDA/USPTO collaboration
• Dissecting FDORA and 2023 FY legislative priorities
• Proposed GDUFA riders included in FDORA
• GDUFA II user fees, guidances and MAPPs
• Exploring how FDORA is influencing pharmaceutical patent litigation
• Detailing the impact of recent FDA and related litigation on brands and generics
• Melinta v. FDA
• Avadel v. FDA
• Sandoz v. Becerra
• Vanda v. FDA
• Avadel v. Jazz

Best Practices for Utilizing FDA’s Citizen Petition Process: Brand and Generic Recommendations for Achieving Market Access and Petitions for Reconsideration

Ryan Kaat
Assistant General Counsel
PhRMA

Sara W. Koblitz
Director
Hyman, Phelps & McNamara PC

In this session, panelists will demystify the 505(q) Citizens Petition process, equipping Hatch-Waxman litigators with the knowledge and tools to effectively utilize this valuable regulatory tool.

Topics of discussion will include:

• Leveraging 505(q) Citizens Petitions as a strategic tool in Hatch-Waxman litigation
• Examining how 505(q) petitions have impacted FDA drug approvals
• Understanding of the petition process, including the nuances of drafting, submission, and navigating potential challenges
• Understanding the criteria FDA considers when evaluating a petition
• How does FDA determine the petition’s primary purpose was to delay?
• Analyzing market exclusivities to be addressed in the petition
• Detailing what should be included and what the process entails
• Taking stock of recent decisions involving Citizens Petitions
• Best practices for the reconsideration process and litigation

Networking Coffee Break

FTC KEYNOTE

Antitrust Developments Concerning Brands & Generics

Rebecca Egeland
Attorney
Federal Trade Commission

A 360 Degree Examination of Reverse-Payment Settlements: Non-Monetary Provisions, State Legislation, Expert Testimony, and Recent Litigation

Richard Kurz
Partner
Haug Partners LLP

Eric Grannon
Partner
White & Case LLP

Tasha Francis Gerasmiow
Partner
Kirkland & Ellis LLP

Ted Mathias
Partner
Axinn, Veltrop & Harkrider LLP

• Analyzing recent trends in how agencies and courts approach reverse payments
• In re Zetia
• In re Glumetza
• Understanding settlement strategies from the perspectives of brands and generics
• Structuring agreements and identifying antitrust concerns
• Understanding investigation and liability risks
• Highlighting the state legislation directly addressing “reverse payment” patent settlements
• Presumption of unlawfulness – California AB 824
• Which states have modeled their legislation after California?
• Reviewing the proper standards of antitrust review and the rising call for a legislative response
• Avoiding costly litigation and associated penalties by effectively complying with the law
• At-Risk Launch considerations

Networking Luncheon

THE PTAB LIVE!

The APJs Speak on Practices, Policy and Procedure

Honorable Grace Obermann
Administrative Patent Judge, Patent Trial & Appeal Board
U.S. Patent and Trademark Office

Honorable Linda Horner
Administrative Patent Judge, Patent Trial & Appeal Board
U.S. Patent and Trademark Office

Moderator:

William Zimmerman
Partner
Knobbe Martens

• Surveying notable pharmaceutical patent wins and losses
• Reviewing IPR, PGR and CBM filings involving pharmaceutical patents
• Examining the latest statistics for types of challenges brought and types of patents challenged
• Examining when the PTAB will issue a “good cause” extension of trial
• Considering emerging case law shaping the role of prior art in the PTAB’s discretionary denial of inter partes review
• Evaluating when petitioners may rely on prior art previously considered by the PTAB

A Comprehensive Handbook for Pharmaceutical Patent Litigation Funding and Alternative Fee Arrangements

Ryan M. Daniel
VP, Associate General Counsel, Corporate and Business Transactions
Biopharmaceuticals
Fresenius Kabi, LLC

Kevin Nelson
Partner
ArentFox Schiff LLP

Justin A. Maleson
Director
Longford Capital Management LP

Litigation funding can help businesses pay for legal fees and expenses, including increasingly costly expert fees. Alternative fee arrangements can provide risk averse litigants with the confidence to see cases through to their conclusion, even against the best-capitalized defendants. In this interactive practical session, topics of discussion will include:

• Reviewing litigation funding and other alternative fee arrangements and the advantages for litigants
• Assessing risk-sharing solutions to provide better predictability and value
• Recognizing the essential criteria of a feasible funding opportunity based on meritorious claims
• Analyzing the mechanics of the financer’s underwriting process
• Exploring the key modules of a pharmaceutical patent litigation funding agreement

Afternoon Break

ETHICS CASE STUDIES

Cybersecurity, Information Security, and the Ethical Protection of Data

Tom Irving
Partner
The Marbury Law Group, PLLC

Kevin E. Noonan
Partner
McDonnell Boehnen Hulbert & Berghoff LLP

Shashank Upadhye
Partner
Upadhye Tang LLP
(Former Vice President – Global IP, Apotex, Inc.)

Attorneys oversee myriad of sensitive information daily, and confidentiality is a core tenet of the legal profession. Now, more than ever before, cybersecurity must be an ever-present priority for Hatch-Waxman practitioners. This session will offer best practices for protecting your clients’ information, identify the main risks specific to the life sciences and intellectual property, and provide proven strategies on optimizing your firm’s cybersecurity approach that you can immediately implement.

Conference Concludes